Zinc sulphate enema for the management of non-infectious mild to moderate distal colitis
| ISRCTN | ISRCTN87269559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87269559 |
| Protocol serial number | N0064109021 |
| Sponsor | Department of Health (UK) |
| Funder | Sandwell and West Birmingham Hospitals NHS Trust - City Hospital (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 15/11/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr AM El-Tawil
Scientific
Scientific
Department of Gastroenterology
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
| Phone | +44 (0)121 554 3801 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To examine the effect of zinc sulphate solution enema on patients with mild to moderate distal colitis. Although it is appreciated that Crohn's disease and ulcerative colitis result in malabsorption of a variety of nutrients and that hypozincemia may occur in patients with Crohn's disease or ulcerative colitis, relatively little investigation has been directed toward the sequel of zinc deficiency in this disorder. We assume that zinc has an anti-inflammatory power. If this approach proves effective then it is likely to alleviate much suffering. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Colitis |
| Intervention | Single centre, patient volunteers, prospective, controlled, therapeutic, observational, double-blind, placebo, drugs, invasive procedures, randomised. FUNDING NOT SECURED AND TRIAL NOT STARTED AS OF APRIL 2005. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | 60 patients. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2002 |
| Date of final enrolment | 01/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Gastroenterology
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
